Earlier this year, Teva Pharmaceutical disclosed an internal investigation found business practices that were “likely” violations of the Foreign Corrupt Practices Act. The drug maker began its probe after receiving subpoenas and other requests for information related to foreign bribery from the U.S. Securities and Exchange Commission and the U.S. Department of Justice Department in 2012 (see page 6).

The run-up to that revelation, however, was allegedly fraught with internal bickering over procedures for pursuing violations, according to a lawsuit filed by a former Teva employee. Moreover, Keisha Hall, a one-time Teva certified fraud examiner and director of finance for Latin America, claims she was eventually fired for disagreeing with supervisors and helping U.S. officials with their investigation.

Teva is only the latest drug maker to become immersed in FCPA issues. U.S. officials are actively scrutinizing the pharmaceutical industry. Meanwhile, GlaxoSmithKline, Sanofi and the Alcon eye unit at Novartis, for instance, have been running internal investigations into potential problems in various countries. Four years ago, Johnson & Johnson paid $70 million to resolve FCPA violations.

As for the allegations made by Hall, her lawsuit claims that, from the time she arrived at Teva in 2008, she became aware the Latin America region had a history of events related to corruption. For instance, she claims she learned of investigations conducted by outside counsel earlier that year who identified numerous FCPA violations, according to the lawsuit, which was filed in federal court in Florida this week.

These included unauthorized payments to doctors in Chile and bribing doctors working for government hospitals, according to the lawsuit. She also alleged various investigations related to FCPA violations had been conducted between 2007 and 2010 by third parties, each of which resulted in findings and remediation recommendations.

Specifically, Hall was assigned to develop forms for tracking sales and marketing activities, and to develop a portal for automatically recording data, according to the lawsuit. However, Hall claims in her lawsuit that she later ran into roadblocks after some Teva managers allegedly sought to alter procedures for gathering information that is supposed to be collected to ensure compliance with the law.

After Hall began reporting to a different manager, she was told “the role of compliance was not to interfere with the business-related needs of the company,” according to the lawsuit. And her new manager was “not too concerned with the FCPA” because violations would “only result in fines,” the lawsuit states, adding that many monitoring controls and compliance mechanisms were dismantled.

As a result, the level of monitoring in Latin America, notably Argentina, declined and managers ignored reports of the fraudulent payments to the Mexican government, according to the lawsuit. But despite making suggestions to maintain certain practices, she and her supervisor were eventually overruled, the lawsuit alleges.

By 2013, shortly after Teva began an internal probe, the lawsuit states Hall was asked to provide testimony to investigators for the SEC and Justice Department that covered events dating back a few years. These included internal disagreements over memos outlining deficiencies in complying with the Sorbanes-Oxley Act, which regulates corporate governance and financial practices.

Last year, Hall took a maternity leave and applied for a promotion, but instead, was told an anonymous whistleblower alleged she had inappropriately used Teva equipment – notably, a laptop – for personal use, according to the lawsuit. She was fired last November. Teva also claimed Hall was terminate dfor “instigating conflict, but alleged no misconduct associated with work,” the lawsuit says.

A Teva spokeswoman writes us that the allegations are “entirely false” and that Hall was fired for violating company policy. The lawsuit, for instance, recounts how Hall was told she inappropriately used Teva equipment for personal business. The drug maker will “vigorously defend the allegations,” the spokeswoman writes.

Good morning, everyone, and how are you today? The heat continues to rise here on the Pharmalot campus, where we are hoping for storm clouds to wash away the humidity that has characterized the past few days. One can dream, yes? To cope, we are quaffing some cups of stimulation and distracting ourselves by foraging for items of interest. Toward that end, we have assembled a few below. Hope you find these helpful and have a cool day. Keep in touch…

GlaxoSmithKline, which was fined a record $483 million for corruption in China last year and is examining possible staff misconduct elsewhere, faces new allegations of bribery in Romania, Reuters reports. The drug maker confirmed it was looking into the latest claims of improper payments set out in a whistleblower’s email sent to its top management on Monday. Previously, Glaxo acknowledged there were bribery allegations in Poland, Iraq, Jordan, Lebanon and Syria.

The Delhi High Court in India has dismissed a plea from AstraZeneca to block Lee Pharma from making copies of its Onglyza diabetes drug and is leaving it for the patent office to decide whether to grant a compulsory license for the medicine, The Economic Times reports. We recently noted that Lee Pharma is seeking a license on the grounds that the drug is not sold at an affordable price in India and that supplies are inadequate. The battle comes as the Indian government faces increasing pressure over intellectual property rights.

MannKind, which makes the Afrezza inhaled insulin, is using a mix of discounted stock and more debt to settle a $100 million convertible loan about to come due, TheStreet tells us. The stock-for-debt exchange, which covers a bit more than half of its obligation, is the worst part of the agreement because the exchange price of the stock is determined by the price of Mannkind shares over the next 10 trading days. This is the classic definition of a death-spiral convert, a form of distressed financing which forces companies to hand over more shares when the stock price falls.

Depomed rejected a revised, $1.98 billion takeover proposal from Horizon Pharma, saying it undervalues the company, because the higher bid simply reflected a rise in the stock price and did not represent a true increase, according to Bloomberg News.

Express Scripts, the largest pharmacy benefit manager in the U.S., says the cost of the newly approved PCSK9 inhibitor cholesterol drugs could “wreak financial havoc” among its clients, Reuters tells us.

Tax savings drove the Valeant Pharmaceuticals acquisition strategy, according to an advance copy of U.S. Senate committee report and testimony prepared for a hearing today, Bloomberg News.

Sun Pharmaceuticals is cutting R&D staff as it digests the $3.2-billion acquisition of Ranbaxy Laboratories, a move that comes a month after about 150 senior executives were asked to leave, The Economic Times says.

A shipment of drugs stolen while a truck driver went home to change his clothes were recovered in half an hour thanks to a GPS tracking device embedded in the cargo, InPharma Technologist confides.

The FDA approval process for drug-device combinations would become more streamlined under the Combination Product Regulatory Fairness Act recently introduced in the Senate, Clinica writes.

U.K. investor Neil Woodford is backing a start-up called Mereo Biopharma that will run clinical trials of three drugs developed by Novartis, which is taking an equity stake in return for the assets, Reuters reports.

Wendy’s is starting to test new chicken products made from poultry raised without antibiotics, the latest sign of a broad industry shift away from the drugs in the U.S. meat supply chain, The Wall Street Journal writes.

The FDA has granted breakthrough therapy designation status to Eisai’s Lenvima treatment for renal cell carcinoma based on results of a Phase II study, Pharma Times reports.

Top of the morning to you. And a steamy one, it is. In fact, there is more steam rising from the grounds of the Pharmalot campus than from our ritual cup of stimulation. But this is to be expected at this time of year, yes? In any event, there is work to be done, so as always, we have assembled a few items of interest for you. After all, the world keeps spinning no matter what the thermometer says. Hope you have a successful day and conquer the world. And of course, do keep in touch…

Merck plans to target hard-to-treat hepatitis C patients rather than compete for market share by drastically undercutting the price of Gilead Sciences’ $1,000-a-day treatment, Bloomberg News writes. Meanwhile, the FDA accepted a Merck application for approval of its single pill medication, which combines two compounds, and granted the medicine a priority review. This means the drug maker is on course to introduce the treatment to patients early next year.

None of the nine drug makers accused of avoiding paying taxes in Australia have been taken to court, The Sydney Morning Herald reports. A recent Senate inquiry heard how the companies use transfer pricing and then make royalty payments to their overseas subsidiaries. The inquiry heard that nine drug makers – Johnson & Johnson, Pfizer, GlaxoSmithKline, Merck, Eli Lilly, Novartis, AstraZeneca, Roche and Sanofi – had collectively paid a tax bill of only $85 million, despite notching more than $8 billion in sales.

Sanofi agreed to contribute $2.2 billion to work with Regeneron Pharmaceuticals on therapies that harness the immune system to fight cancer, Bloomberg News informs us. The move is a bet on an increasingly crowded field of research into tailoring the body’s defenses to attack cancer. The Regeneron drug, which is in early-stage trials, targets a protein known as PD-1 that restricts the ability of the immune system to fight tumors. Other large drug makers also pursuing drugs with that approach include Merck, Roche, AstraZeneca and Bristol-Myers Squibb.

Hikma Pharmaceuticals agreed to buy Roxane Laboratories from Boehringer Ingelheim for about $2.65 billion in cash and stock, making it the sixth-largest generic supplier in the U.S., Reuters writes.

Aegerion Pharmaceuticals ceo Marc Beer, a controversial figure who was chided by the FDA for statements made on CNBC, has resigned, six months after some investors pushed for him to depart, Xconomy reports.

Mylan Laboratories has set Aug. 28 for a special shareholder meeting to determine whether to go ahead with its unsolicited $28.9 billion bid for Perrigo, The Pittsburgh Business Times says.

Amid ongoing litigation against NHS England and generic rivals, Pfizer is pushing for changes to physician software to ensure only brand-name Lyrica is prescribed for neuropathic pain, Pulse Today reports.

Boehringer Ingelheim is pulling out of a deal with Vitae Pharma to develop so-called BACE inhibitors for combating Alzheimer’s disease, six months after a clinical hold was placed on a compound, BioSpace says.

GVK Biosciences is considering selling part or all of its clinical trials business, following concerns by regulators that ECG data of trial subjects was manipulated at its Hyderabad facility, according to The Economic Times.

Biogen may have to make a bold move to reassure investors — buying back shares or acquiring a smaller company — or the biotech giant could become a takeover target, The Boston Globe tells us.

As the number of approved clinical trials in India continues to taper off compared to years past, a government task force is now calling for a new expedited trial approval process, Outsourcing Pharma says.

The FDA is warning that gadolinium-enhancing contrast agents used in MRI imaging may build up in the brain after repeated scans, says MedPage Today.

And so, yet another working week will soon draw to a close. You knew this would happen, yes? As you know, this is our treasured signal to daydream about weekend plans. As is often the case, we have a rather modest agenda. We hope to catch up on paperwork and reading, indulge the short people and take a nap or three. And what about you? This is, of course, a grand time to enjoy the great outdoors or catch up with some favorite people. Perhaps planning a getaway is in order. Whatever you do, have a swell time, but be safe. See you next week…

The European Medicines Agency has recommended Praluent, a new type of cholesterol-lowering treatment from Sanofi and Regeneron Pharmaceuticals, for patients unable to control their cholesterol despite taking optimal doses of conventional statin pills or who cannot take statins, Reuters reports. Known as a PCSK-9 inhibitor, the drug may also be approved today by the FDA, and Amgen is also awaiting approval for its own medicine. The big story Wall Street and payers will be watching will be pricing.

A GlaxoSmithKline malaria vaccine has cleared its final scientific hurdle, but it could still take up to a year before immunization programs begin in sub-Saharan Africa, The Wall Street Journal writes. The vaccine, which is aimed at young children, received a positive scientific opinion from the European Medicines Agency, but its eventual rollout depends on a series of decisions by stakeholders including the World Health Organization, individual governments in sub-Saharan Africa, and GAVI, the Vaccines Alliance, which is expected to subsidize the programs.

As UnitedHealth Group bulks up, the insurer is negotiating tougher terms with drug makers to rein in costs, pushing for refunds when medications do not work for patients, Bloomberg News reports. Its Optum Rx pharmacy-benefits business recently completed the acquisition of rival Catamaran, giving it increased scale in talks with drug makers. And Mark Thierer, who now runs the combined benefits manager, says OptumRx has already worked out a deal with Gilead Sciences to tie payments to the performance of the drugmaker’s hepatitis C treatments.

Last year, Kentucky spent more than $50 million, about 7 percent of its total Medicaid budget, providing two Gilead Sciences hepatitis C drugs, Sovaldi and Harvoni, to just 861 people, The New York Times says.

Lupin which is India’s third-largest drug maker, is buying Gavis Pharmaceuticals for $880 million in its largest ever acquisition as it seeks to revive its flagging growth in the U.S., Reuters tells us.

Sandoz is closing three plants – two in Germany and one in India – by the end of 2016 and eliminating 770 jobs as part of a cost-cutting drive, InPharma Technologist writes.

AstraZeneca agreed to jointly develop a version of Roche’s Avastin cancer drug with a Japanese company to gain access to another combination treatment for its oncology pipeline, Bloomberg News tells us.

MRL Ventures, Merck’s early-stage biotech investment arm, has agreed to join The Baupost Group in leading a $55 million Series B venture investment in RaNA Therapeutics, Forbes explains.

The Indian Patent Office, for the second time, has rejected Roche’ patent claims on its Valcyte drug, which is used to treat an eye infection affecting AIDS patients, The Economic Times says.

AstraZeneca formed a pact with Adherium to combine digital health technology with inhaler medications to boost health outcomes, according to Pharma Times.

Boehringer Ingelheim Pharma and Teva Pharmaceuticals will be permitted to ask a federal appeals court to dismiss a class action accusing them of conspiring to keep a generic version of the Aggrenox stroke prevention drug off the market, Reuters reports.

In an unprecedented move, a group of 85 asset managers and pension funds is teaming with a U.K. non-profit campaign to pressure drug makers to disclose clinical trial data. The effort is likely to escalate a closely watched battle that has increasingly placed the pharmaceutical industry on the defensive as researchers and regulators call for increased disclosure.

The investors, which collectively manage about $3.8 trillion, plan to meet with drug makers in which they invest to ensure that trials are registered and results are reported, according to Sile Lane, campaign director at Sense About Science, a non-profit that launched the AllTrials campaign in the U.K. to agitate for greater trial data disclosure.

Drug makers will be asked to retrospectively register past and ongoing clinical trials, and register all future trials before they begin;publish methods and full results of all trials, include information on adverse events; post objective summary results within one year of completing a trial, and support efforts to provide independent researchers access to anonymized individual patient data, according to a statement.

“We believe this is going to be game changing,” Lane tells us. To facilitate the process, the AllTrials campaign is conducting an audit of disclosure policies for the 50 largest drug makers and willscore each one. The results are expected to be published in September. “This will become a tool readily available to investors,” she says.

The move comes amid growing clamor from academics and consumer groups to press drug and device makers to release trial data. At issue is the ability for researchers to independently verify study results and, consequently, improve patient treatments that can lead to better health and lower costs.

Concerns have been heightened following various safety scandals that revealed trial data for some products was never fully published or disclosed. In recent months, regulators in the U.S. and Europe have responded by releasing new rules designed to widen access. And several drug makers, in varying degrees, have taken steps to release trial data.

For instance, GlaxoSmithKline created a website where data requests are made to 10 different drug makers, Johnson & Johnson is working with Yale University to provide access to data, and Bristol-Myers Squibb will grant access to academics as part of a collaboration with Duke University. AstraZeneca formed a panel to review requests for data, although questions were raised about its independence.

But critics say such efforts are few and far between. Helena Vines Fiestas, who heads sustainability research at BNP Paribas Investment Partners, says there is increasing concern that a lack of transparency about medicines – past and present – is having a negative impact on stock valuations. BNP got involved as an outgrowth of a broader effort to rate and benchmark companies in different industry sectors.

For instance, she says fines paid by 21 drug makers for marketing malfeasance between 2007 and mid-2015 was $40 billion, and 43% was directly related to minimizing side effects that were identified during clinical trials but not properly reported. Her team also queried analysts and discovered that an average of about 30% of drug company stock valuations directly relate to results of Phase III clinical trials.

“The lack of complete and unbiased information can mislead decisions made not only regulators and doctors, but also investors,” Fiestas tells us. “We think if the companies become more transparent and take the issue around auditing and reports more seriously that the decisions made by analysts can be more closely aligned with reality.”

Whether this latest move to raise pressure on drug makers will work remains to be seen. Harlan Krumholz, a Yale University cardiologist who heads the Yale Open Data Access project, is skeptical that the funds can make a difference. “It seems to me that they have signed on – and are cheerleading – but I’m not sure of the influence they have,” he says.

Similarly, Ira Loss, a senior health care analyst at Washington Analysis, a consulting firm, says it is unclear whether many funds will use the AllTrials audit and join the campaign, even if they support the goals. “There are various criteria used for choosing investments,” he says. “I don’t know if it’s workable. In some places it might affect investment decisions.Being in favor of the goal is one thing, but not investing in a company that doesn’t sign up may be a bridge too far.”

Still, Krumholz praises AllTrials for its efforts. “This group deserves credit for giving attention to the problem of publication bias, which undermines the validity of medicine’s evidence base and precludes truly informed choice. If we are missing important results – and the picture that we are getting is biased – then we cannot fully trust that what we think we know about the effectiveness and safety of drugs and devices is really true. It is time to fix this problem – and Alltrials is making an important contribution.”

Hello, everyone, and how are you today? A bright shiny sun and cool breezes are enveloping the Pharmalot campus, a decidedly welcome greeting from the steamy heat of the past few days. This calls for celebration. So please join us as we reach for the mandatory cup of stimulation. There is another reason to celebrate, by the way, and that is the middle of the week has arrived. In other words, you made it this far, so why not continue? Consider the alternatives, after all. Meanwhile, here are some tidbits. Have a great day and keep in touch…

A 6 mg dose of Biogen 's experimental Alzheimer’s drug significantly reduced beta amyloid plaque in the brain but failed to significantly slow mental decline, potentially tempering great enthusiasm that greeted data on two other doses of the treatment released earlier this year, Reuters writes. Meanwhile, people with mild Alzheimer’s disease who started taking an experimental Eli Lilly drug earlier in the course of their disease fared better than patients who started later in a clinical trial, according to The Wall Street Journal.

AstraZeneca 's much anticipated cancer drug pipeline suffered a blow on when its experimental selumetinib drug failed to meet its goal in a late-stage trial for uveal melanoma, Reuters reports. The drugmaker said the setback would not affect other studies using the drug. Selumetinib is being investigated primarily as a treatment for advanced non-small cell lung cancer. Selumetinib belongs to a class of cancer drugs known as MEK inhibitors.

Four drugmakers - Teva Pharmaceutical, Amgen, Eli Lilly and Alder Biopharmaceuticals – are developing the first generation of drugs to prevent migraines and all have blockbuster potential, according to Bloomberg News. The treatments, which are designed to target a peptide known to touch off the pain attacks, have so far shown they work for about half of migraine victims tested. Analysts say the makret is worth between $4 billion and $8 billion and relieve the recurring spells that cost the U.S. economy an estimated $13 billion a year in lost work productivity.

More than 1 in 5 sexually active teen girls have used the morning-after pill — a dramatic increase that likely reflects that it’s easier now for teens to buy the emergency contraceptive, the Associated Press informs us. A U.S. Centers for Disease Control and Prevention survey shows teen use of the morning-after pill rose steadily from a decade earlier, when it was 1 in 12. Now, all teens can buy it without a prescription. The report showed little recent change in most other types of birth control used by teen girls who have had sex.

Bristol-Myers Squibb says the FDA granted breakthrough status to an experimental HIV drug that is to be used with other antiretroviral drugs in adults who have already developed resistance other HIV treatments, the Associated Press says.

GlaxoSmithKline accused a software developer of violating federal copyright law by selling a custom software package that was allegedly created in partnership with the drug maker, The Triangle Business Journal writes.

A federal judge rejected a last-ditch attempt by Bristol-Myers Squibb to save a lawsuit accusing Mylan Laboratories of breaching an agreement to distribute an AIDS drug in developing countries, refusing to reconsider his order dismissing the case, Reuters reports.

The European Union will soon give the United States a formal proposal for revamping an investment dispute settlement mechanism that has raised concerns in Europe over the proposed Transatlantic Trade and Investment Partnership pact, Politico tells us.

Novartis remains bullish about prospects for its blockbuster cancer drug Afinitor, which achieved sales of $1.58 billion last year, despite competitors lining up to challenge its market position, Reuters says.

Merck’s anti-PD-1 therapy Keytruda has been approved in Europe for the treatment of advanced skin cancer, after trials showed it offered a superior survival benefit as a monotherapy compared to Bristol-Myers Squibb’s Yervoy, Pharma Times writes.

Pfizer plans to consolidate operations at several Cambridge locations and move hundreds of employees into a huge, unified research campus outside of Kendall Square, The Boston Globe says.

Good morning, everyone, and welcome to another working week. We hope the weekend respite was refreshing and invigorating because, once again, that familiar routine of deadlines, meetings and what not has returned. You knew this would happen, yes? As always, we are coping by quaffing cups of stimulation and, of course, invite you to join us. While you do, you can also peruse the latest list of interesting items to help you get started. Hope you have a smashing day and do stay in touch…

An estimated 2,000 children die of cancer each year and the overall incidence has been slowly increasing since 1975, but despite significant advances against certain pediatric cancers, there are still some types of cancer for which there are few or no effective treatments because, new drug development in the field is slow, often lagging way behind adult treatments, and few compounds are designed specifically for children, Newsweek writes. Childhood cancers make up less than 1% of all cancers diagnosed each year, which is not much of a market for drugmakers.

Legislation that would force drug makers to publicly disclose their profits on certain high-cost drugs, along with their research, manufacturing and advertising expenses are nothing but price controls, Roberg Ingram, a board member at Valeant Pharmaceuticals and Regeneron Pharmaceuticals writes in The Wall Street Journal. “There is no surer way to bring pharmaceutical innovation to a halt in the U.S. than letting governments decide how much companies can charge for their products or harassing them into lower prices.”

New data from a long-term study presented yesterday at a major Alzheimer’s disease conference suggest that a battery of well-known memory, brain-imaging and biological measures could help predict whether an individual without apparent memory problems will develop the disease within six years, The Wall Street Journal writes. Such biomarkers could help drug makers select the most appropriate patients for experimental drug trials, and if medicines that slow down the course of disease become available, help identify patients and get them into treatment earlier.

Patients without heavy burdens of beta-amyloid plaques throughout their brains may still be vulnerable to Alzheimer’s disease and related pathologies, especially when localized deposits interfere with critical brain networks, MedPage Today writes.

Six big drug makers – Novartis, Bristol-Myers Squibb, Eli Lilly, Valeant Pharmaceuticals, AbbVie and Biogen – all report earnings this week and Investor’s Business Daily provides a rundown of what to expect.

Exelixis is releasing data today from a clinical trial that should breathe new life into its Cometriq cancer drug, which suffered a setback in a study released last fall, Forbes writes.

Pfizer has more collaborations with British universities than any other foreign company, and had the third most collaborations overall behind GlaxoSmithKline and Rolls-Royce, The Financial Times tells us.

General Electric hopes its life sciences division, one of its fastest-growing niche businesses, will play the role of industry disruptor as the manufacturing of biotech drugs shifts from big-batch production toward more flexible systems, The Boston Globe says.

Wockhardt is recalling thousands of cartons of various drugs that are used to treat ailments like high blood pressure and ulcer, from the U.S. market due to deviations in current good manufacturing practice norm, The Economic Times writes.

Demand for over-the-counter medicines in the U.K. rose by 6% in the year ending February due, in part, to government promotion of self-care medicines and budget squeezes, according to Pharma Times.

Utah attorneys defending a hotly contested law banning minimum prices for contact lenses argued this week that the state has the right to regulate industry price-fixing even if the products are sold to customers elsewhere, the Associated Press says.

Rise and shine. Another busy day is on the way, although the Pharmalot campus is unusually quiet this morning. The shortest of short people has already departed for some summer fun and the official mascots are happily snoozing. Such a sleepy atmosphere calls for some stimulation, yes? So please join us for a cup or three. We are quaffing french vanilla, for those keeping track. And remember, no prescription is required. Meanwhile, here are some tidbits. Have a wonderful day and do stay in touch…

The European Medicines Agency has launched a safety review of the three human papillomavirus vaccines after receiving reports of serious adverse reactions in some young women, The Washington Post writes. The incidents were rare, but the EMA is “concerned” by the severity of two conditions. The first is known as complex regional pain syndrome or CRPS and is a chronic pain condition affecting the limbs. The second one, postural orthostatic tachycardia syndrome or POTS, occurs when the heart rate jumps abnormally when sitting or standing.

The FDA banned drug imports from an India manufacturing unit of Emcure Pharmaceuticals over violations of standard manufacturing practices, the latest in a series of Indian firms to face such action, Reuters reports. Emcure, which is one of India’s top 20 drugmakers, is the latest among some of India’s largest drugmakers to have come under fire for similar violations in the last few years, hurting the country’s reputation as a reliable supplier of cheap generic drugs to the world, and impacting the growth of the $15 billion industry.

Omnicare reached an agreement with the federal government over how much it will pay to settle a lawsuit that alleges the firm sought and received tens of millions of dollars in kickbacks from Abbott Laboratories, The Cincinnati Business Courier reports. The whistleblower suit, filed in December, claims Omnicare got kickbacks from 1998 through 2008 for buying and recommending the drug Depakote to control the behavior of dementia patients.

After AbbVie ended a hostile takeover effort, Shire ceo Flemming Ornskov has been pushing the drugmaker to become a biotech, The Wall Street Journal writes. To do so, he is taking the company in new directions treating brain, eye and stomach diseases, and saying goodbye to hundreds of employees at a Pennsylvania site being downsized. He is also pursuing deals, such as the recent $5.2 billion acquisition of NPS Pharmaceuticals, which will help Shire fulfill a pledge to nearly double sales to $10 billion in 2020, as well as further its transformation.

Greece has decided to ban the export of some drugs following what it said were abuses on re-exporting imported medicines, according to Reuters, citing a Health Ministry spokeswoman.

GlaxoSmithKline and Purdue Pharma want to use Apple’s open source ResearchKit platform for gathering medical research data via the iPhone, according to BuzzFeed.

The FDA approved AstraZeneca’s Iressa as a first-line treatment for a common form of lung cancer, based on results from a trial of 106 patients with previously untreated non-small cell lung cancer, Reuters says.

The Japanese health ministry hopes to save more than $10 billion by aiming for 80% of prescriptions dispensed in the country to be generics by 2017, The Japan Times reports.

A popular new type of prenatal test intended to find genetic flaws in a fetus can in rare cases also reveal previously undiagnosed cancer in the mother, The Wall Street Journal informs us.

Hello, everyone, and how are you today? We are doing just fine, thank you. Despite some gloomy clouds hovering overhead, our spirits remain sunny. After all, every brand new day should be unwrapped like a precious gift. So why not celebrate a wee bit? We are doing so, in fact, with yet another cup of delicious stimulation – we are back to southern pecan – and invite you to join us. Anything to help the neurons stay awake, right? Meanwhile, here are some tidbits to get you going. Have a smashing day and keep in touch…

HIV drugs are proving to be so effective in containing the virus that GlaxoSmithKline foresees a time, a decade away, when its most profitable business unit may no longer have a purpose, Bloomberg News writes. “There are diminishing returns in HIV,” says David Redfern, Glaxo’s chief strategy officer and the chairman of its AIDS treatment unit ViiV Healthcare. “The industry has done a fantastic job of taking the fear of the late ’80s, and the death sentence, and taking that to one tablet a day.”

An inexpensive, little-known cholera vaccine appears to work so well that it can protect entire communities and perhaps head off explosive epidemics like the one that killed nearly 10,000 Haitians in 2010, The New York Times reports. A study published yesterday in The Lancet found that the vaccine gave individuals more than 50% protection against cholera and reduced life-threatening episodes of the infection by about 40% in Bangladesh, where the disease has persisted for centuries.

UC San Diego has filed a lawsuit accusing USC and a nationally recognized Alzheimer’s disease researcher of allegedly conspiring to take federal funding, data and employees from a UC San Diego study center on the illness, The Los Angeles Times informs us. The lawsuit charges that Paul Aisen and eight colleagues illegally conspired to take research data and other assets when they moved from UC San Diego to USC, allegedly seeking to supplant their former center. Aisen left UC San Diego last month to head a new Alzheimer’s institute founded by USC in San Diego.

South Carolina’s highest court further reduced the penalty against a Johnson & Johnson subsidiary accused of deceptive marketing of an anti-psychotic drug, the Associated Press writes. In its ruling, the state Supreme Court ordered Janssen to pay about $124 million — more than $200 million less than the original penalty amount. In 2011, a trial court ordered the drug maker to pay $327 million, saying Janssen broke the law by downplaying to doctors the links between diabetes and Risperdal and by improperly claiming the drug was safer than rival meds.

23andMe ceo Anne Wojcicki says consumers worried about having their genetic information shared with the pharmaceutical industry can always opt out, Business Insider writes. “We do a lot of partnerships with a lot of pharma companies because we do feel like that’s in the best interest of the consumer in order to make meaningful discoveries from the data,” she says. “But if a consumer doesn’t like what we do, they always have the ability to close their account, delete their data, and not be involved in any more research.”

The Trans-Pacific Partnership countries are gearing up for a highly-awaited ministerial meeting at the end of July, in a gathering that many officials predict could bring the talks to a close, Bridges tells us.

A federal judge narrowed a $100 million collective action lawsuit accusing Forest Laboratories, which is now part of Allergan, of discriminating against female sales reps because their claims may be time-barred, Reuters writes.

A new final rule from the FDA requires all drug makers to notify the agency electronically of a permanent discontinuance or an interruption in manufacturing six months in advance before the disruption causes a shortage, InPharma Technologist says.

Cleveland Clinic Innovations parted with executive director Gary Fingerhut, a move triggered by an investigation from a “government agency” over financial transactions by one of the health system’s spinoff companies, MedCity News writes.

Sanofi is extending its collaboration with Medicines for Malaria Venture to jointly develop a one-shot, fixed-dose combination therapy for malaria, according to Pharma Times.

And so, another working week will soon draw to a close, at least on this side of the pond, where a holiday is just around the corner. As a result, we are getting an earlier-than-usual opportunity to daydream about weekend plans. Hooray! Our agenda is modest, but we do look forward to spending time with assorted short people, catching up on our reading and planning the future, a particularly important goal lately. But what about you? This is a good time to catch up with friends or family. You could try out a new recipe if you like to grill. Or perhaps this is simply a chance to catch your breath, so to speak. Well, whatever you do, have a grand time, but be safe. See you soon…

China will receive cut-price supplies of GlaxoSmithKline 's new HIV drug Tivicay thanks to a deal for Desano Pharmaceuticals to become an additional manufacturer of the active ingredient in the drug, Reuters reports. The collaboration between GSK’s HIV unit ViiV Healthcare and Desano, which is based in Shanghai, marks an improvement in the business climate for the British drugmaker, which was fined a record $484 million in September for bribing Chinese doctors.

India’s health ministry is studying regulatory dictates in other countries to create and set a benchmark for quality and good manufacturing practices globally, PharmaBiz tells us. ”There is a growing need for drugs standardization, compliance and regulatory requirements to be at par with international regulations, including the US FDA, allowing drug manufacturers to maintain competitive advantage,” an unnamed government official says.

Dong-Pyou Han, a former biomedical scientist at Iowa State University in Ames, was sentenced to 57 months for fabricating and falsifying data in HIV vaccine trials, Nature News writes. Han has also been fined US$7.2 million and will be subject to three years of supervised release after he leaves prison. The sentence is raising questions about how alleged research fraud is handled in the United States, from decisions about whether to prosecute to the types of punishments imposed by grant-making agencies.

The U.K. health minister Jeremy Hunt announced plans to label all British prescription medicines with their cost to the taxpayer, InPharma Technologist tells us. He says the move “will not just reduce waste by reminding people of the cost of medicine, but also improve patient care by boosting adherence to drug regimes.” And he maintains the strategy is part of a plan to have the public “take more responsibility for use of public precious resources.”

A cancer doctor failed to disclose in a scientific journal that he had received more than $138,000 in cash and goods from Celgene, even though he was assessing the company’s Revlimid drug, Bloomberg News notes. John Bennett, a professor emeritus at New York’s University of Rochester, requested a correction from the journal Leukemia on Tuesday after being contacted by Bloomberg about the omission, which he said was an oversight.

The FDA is investigating all use of codeine-containing cough syrups in children under 18, due to the drug’s potentially life-threatening side effects such as respiratory depression, MedPage Today reports.

The U.K.’s Medicines and Healthcare Products Regulatory Agency says its staff cuts over the next three years will not impact its work with the pharmaceutical industry, InPharma Technologist writes.

The FDA released a pared-down list of diseases it plans to assess over the coming two years as part of its Patient-Focused Drug Development program, an integral part of the most recent authorization of the Prescription Drug User Fee Act, Regulatory Focus reports.

Gilead Sciences submitted a new drug application to the FDA for an investigational, once-daily single tablet combination regimen to treat HIV-1 infection in adult and pediatric patients 12 years of age and older, Pharmaceutical Business Review writes.

Celgene agreed to purchase the vacant 1.3 million-square-foot Merck complex in Summit, adding to what is already a quickly growing footprint in the pharmaceutical giant’s home city, NJBiz tells us.

The FDA is cracking down on companies that make and distribute prescription ear drops because they contain ingredients that have not been approved as safe and effective, including benzocaine and hydrocortisone, The Hill informs us.

Serepta Therapeutics added Henri Termeer, the former Genzyme ceo, as an adviser as the biotech seeks approval for its muscular-dystrophy drug, according to The Wall Street Journal.

A skin-darkening drug can help protect against serious pain in people with a rare inherited condition that makes them flee sunlight like movie vampires, according to tests in Europe and the U.S., Reuters says.

Boehringer Ingelheim’s combination lung drug Spiolto has been approved in its first European countries for treating chronic obstructive pulmonary disease, according to Pharma Times.